A STUDY WITH THE AIM TO EVALUATE THE ANTITUMOR ACTIVITY OF A NEW ASSOCIATION OF ORAL DRUGS, LENALIDOMIDE AND CLARITHROMYCIN IN PATIENTS WITH LYMPHOMA (MALT), WHEN STANDARD TREATMENT WITH RADIATION THERAPY, CHEMOTHERAPY AND /OR IMMUNOTHERAPY HAVE SHOWN A LACK OF EFFICACY
- Conditions
- PATIENTS WITH MUCOSA-ASSOCIATED LYMPHOID TISSUE LYMPHOMA (MALT) FOR WHICH THE STANDARD TREATMENTS WITH RADIOTHERAPY, CHEMOTHERAPY AND /OR IMMUNOTHERAPY SHOW LACK OF EFFICACYTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-003168-35-ES
- Lead Sponsor
- IELSG - INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 68
1) Histologically verified diagnosis of MALT lymphoma arising at any extranodal site
2) Disease refractory to or in first or greater relapse after prior radiotherapy and/or chemotherapy and/or immunotherapy
3)Measurable or non-measurable lesions where the response is nevertheless evaluable by non-imaging means (e.g., gastric or bone marrow infiltrations)
4) Ann Arbor Stage I-IV
5) ECOG performance status of 0, 1 or 2
6) Age = 18 years
7) Life expectancy of at least 3 months
8) Adequate haematological status: ANC (absolute neutrophil count [segmented + bands]) =1.0 x 109/L, platelet count = 75 x 109/L , haemoglobin =8 g/dL.
9) Adequate cardiac, renal and liver function tests (LVEF > 40%, serum creatinine < 2.5 mg/dl, ALAT or ASAT < 2.5 x upper limit of normal range, alkaline phosphatase < 2.5 x upper limit of normal range, serum bilirubin < 2.0 mg/dl)
10) Patient must be willing and able to comply with the protocol for the entire study duration
11) Female patients of childbearing potential must agree to use, and be able to comply with, effective contraception and agree to have medically supervised pregnancy tests prior to starting the study treatment and during therapy
12) Male patients must agree to always use a condom during any sexual contact with females of reproductive potential and agree to not donate sperm while taking lenalidomide
13) Patient must agree to abstain from donating blood while taking study drug therapy
14) Patient must agree not to share study medication with another person and to return all unused study drug to the investigator
15) Patient must be willing and able to comply with the protocol
16) Patient must be capable of understanding the purpose of the study and have given written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34
1) Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma (high grade lymphoma”) - component
2) Use of any investigational agent within 28 days prior to initiation of treatment
3) History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix within the last 5 years unless in complete remission since at least 3 years
4) Dependency on red blood cell and/or platelet transfusions
5) HBsAg positivity
6) Evidence of central nervous system involvement
7) A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
8) Severe peripheral polyneuropathy
9) Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months and/or long QT-syndrome
10) HIV seropositivity
11) Presence of active opportunistic infections
12) Pregnancy or lactation
13) Uncontrolled diabetes mellitus
14) Pre-existing thromboembolic conditions at study entry
15) Known hypersensitivity to thalidomide or lenalidomide or macrolide antibiotics
16) Presence of any contraindication reported on the Summary of Product Characteristics (SmPC) of Clarithromycin
17) Hypersensitivity to any active principle and/or any excipient according to the contraindications reported in the SmPC of clarithromycin and in the Investigator’s Brochure (IB) of lenalidomide
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method